Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
NCT ID: NCT01034462
Last Updated: 2013-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2009-12-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
Levomilnacipran ER
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks
2
Matching placebo capsules, oral administration, once daily dosing.
Placebo
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Interventions
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Levomilnacipran ER
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Placebo
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 4 weeks in duration
Exclusion Criteria
* Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
* Patients who are considered a suicide risk
18 Years
80 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Carl Gommoll, MS
Role: STUDY_DIRECTOR
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Locations
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Forest Investigative Site 055
Dothan, Alabama, United States
Forest Investigative Site 065
Highlands Ranch, Colorado, United States
Forest Investigative Site 057
Boca Raton, Florida, United States
Forest Investigative Site 060
Boca Raton, Florida, United States
Forest Investigative Site 064
Gainesville, Florida, United States
Forest Investigative Site 053
Ocala, Florida, United States
Forest Investigative Site 061
Orlando, Florida, United States
Forest Investigative Site 059
Winter Park, Florida, United States
Forest Investigative Site 070
Atlanta, Georgia, United States
Forest Investigative Site 066
Smyrna, Georgia, United States
Forest Investigative Site 072
Chicago, Illinois, United States
Forest Investigative Site 050
Oak Brook, Illinois, United States
Forest Investigative Site 063
Indianapolis, Indiana, United States
Forest Investigative Site 071
Prairie Village, Kansas, United States
Forest Investigative Site 052
Shreveport, Louisiana, United States
Forest Investigative Site 051
Brooklyn, New York, United States
Forest Investigative Site 056
Oklahoma City, Oklahoma, United States
Forest Investigative Site 067
Oklahoma City, Oklahoma, United States
Forest Investigative Site 058
Salem, Oregon, United States
Forest Investigative Site 054
Allentown, Pennsylvania, United States
Forest Investigative Site 062
San Antonio, Texas, United States
Forest Investigative Site 068
Virginia Beach, Virginia, United States
Forest Investigative Site 069
Spokane, Washington, United States
Countries
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References
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Wesnes KA, Gommoll C, Chen C, Sambunaris A, McIntyre RS, Harvey PD. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study. Int Clin Psychopharmacol. 2017 Mar;32(2):72-79. doi: 10.1097/YIC.0000000000000157.
Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
Sambunaris A, Bose A, Gommoll CP, Chen C, Greenberg WM, Sheehan DV. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder. J Clin Psychopharmacol. 2014 Feb;34(1):47-56. doi: 10.1097/JCP.0000000000000060.
Other Identifiers
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LVM-MD-03
Identifier Type: -
Identifier Source: org_study_id